New vaccine aims to shield infants from deadly pneumonia
NCT ID NCT07017777
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study tests a new vaccine to protect babies against pneumococcal infections, which can cause pneumonia and meningitis. About 600 healthy infants in Thailand will receive either the new or a standard vaccine at 2, 4, and 12-15 months old. Researchers will check how well the vaccine works and if it is safe by tracking side effects and immune responses.
Why investors are watching
CanSino Biologics is running a Phase 3 trial of its experimental pneumococcal vaccine, PCV13i, in 600 Thai infants. The trial compares PCV13i against a control vaccine to see if it triggers a similar immune response and is safe. For a small company like CanSino, a successful readout could add a new product to its pipeline and broaden its vaccine portfolio beyond its existing offerings.
If it works: A positive result could support regulatory approval in Thailand and other markets, giving CanSino a new revenue source. It could also strengthen the company's position in the pediatric vaccine market.
If it fails: The vaccine could fail to show adequate immune response or safety, which would likely end the program and hurt the company's prospects. Trials fail often, and a delay in enrollment or data readout could also weigh on the stock.
AI-written from the trial record. Speculative, and not investment advice.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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600 people
The number who actually took part.
- Started
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Nov 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 weeks to 2 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy infants with stable clinical conditions aged 2 months (42-90 days) at the time of screening, based on medical history and clinical assessment by the investigator. Infants will be eligible starting from the day they turn 6 weeks of age. * Infant's parent or legal guardian must be able and willing to provide informed consent for the infant's participation in the study. * Participants and their parent or legal guardian must demonstrate the ability to comply with all trial procedures and be available for the entire follow-up duration. * The infant's parent or legal guardian must have an easily identifiable and stable place of residence within the study area, be available for the duration of trial participation, and have access to a reliable means of telephone contact for communication with the study team. Exclusion Criteria for the first dose: * Infants born at \<35 weeks of gestation. * Infants who have previously received any pneumococcal vaccine. * Infants currently participating in or who have recently participated in another interventional clinical trial. * Infants with an axillary temperature of ≥37.8°C at the time of enrollment (the participant must be deferred until recovery. The visit may be rescheduled when this criterion is met.) * Infants with any congenital abnormalities, chronic medical conditions, or genetic disorders, severe malnutrition, inherited disease and others, that in the investigator's judgment, may interfere with the study outcomes. * History of anaphylactic shock * History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the experimental and control vaccine * History of epilepsy and convulsions. * Have received immunosuppressive treatment, cytotoxic treatment, systemic steroid treatment for more than 2 weeks, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment of allergic rhinitis). * Received or planned to receive blood/plasma products or immunoglobulins throughout the study period or prior to study vaccination. * History of coagulation disorders or blood conditions that could cause anemia or excess bleeding as judged by the investigator. * Infants with known or suspected immunodeficiency, as determined by medical history and/or physical examination. * Administration of other vaccines within 7 days prior to enrollment. * Any history or current evidence of a condition or therapy that could confound study results, interfere with participation, or is not in the best interest of the participant, as judged by the investigator. * The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel. * Any other condition or situation that, in the investigator's judgment, might interfere with the study or pose additional risks to the participant. Individual termination criteria for subsequent doses: * Severe allergic reaction after the previous vaccination. * Serious adverse events caused by the previous vaccination that is not suitable for subsequent vaccination(s) as judged by the investigator. * Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to discontinue participation is determined by the investigator. * Other reasons for exclusion considered by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
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King Chulalongkorn Memorial Hospital
Bangkok, Thailand
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Phramongkutklao Hospital
Bangkok, Thailand
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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